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INOVIO Announces U.S. FDA Breakthrough Therapy Designation Granted for INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis
• Designation based on clinical evidence indicating INO-3107 may demonstrate substantial improvement over existing therapies • First Breakthrough Therapy
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"• Designation based on clinical evidence indicating INO-3107 may demonstrate substantial improvement over existing therapies\n• First Breakthrough Therapy designation for an INOVIO DNA medicine candidate\nPLYMOUTH MEETING, Pa., Sept. 7, 2023 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for INO-3107 as a potential treatment for patients with Recurrent Respiratory Papillomatosis (RRP). The FDA's Breakthrough Therapy designation is a process designed to expedite the development and review of drug candidates that are intended to treat a serious or life-threatening condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).\n\"This is yet another important step for INO-3107 and recognition that this first-in-class DNA medicine candidate has the potential to improve the lives of patients with RRP,\" said INOVIO's President and Chief Executive Officer, Dr. Jacqueline Shea. \"As we recently announced, we have been interacting with the FDA with the goal to launch a pivotal trial for INO-3107 in the near term. With this Breakthrough Therapy designation, we look forward to continuing to work with the agency so that we can generate the evidence needed to support approval of INO-3107 as quickly and efficiently as possible, with an ultimate aim to help RRP patients and deliver on the promise of DNA medicine.\"\nThe President of the Recurrent Respiratory Papillomatosis Foundation, Kim McClellan, said: \"RRP patients will tell you that even one reduction in the number of disruptive, invasive surgeries they face would be life-changing. The potential impact of this treatment gives me great hope for the future and I'm happy to see that RRP is finally getting the attention it deserves.\"\nINO-3107 is an investigational DNA medicine candidate designed to elicit a targeted T cell response against HPV-6 and HPV-11, the HPV types that cause RRP and other HPV-related disease. This Breakthrough Therapy designation for INO-3107 follows receipt of Orphan Drug designa...